BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2232517 · Received September 2, 2011

    Report

    Report Number
    2531779-2011-06432
    Event Type
    Injury
    Date Received
    September 2, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. REVIEW OF THE TDD BASAL DELIVERY SHOWS PUMP WAS DELIVERING ACCURATELY UP UNTIL THE REPORTED EVENT DATE AND CORRECTLY REFLECTS THE USER'S ACTIVE BASAL PROGRAM. TYPICAL USAGE ALARMS AND WARNINGS WERE OBSERVED IN THE BLACK BOX DOWNLOAD; OBSERVED NO UNACKNOWLEDGED ALARMS, WARNINGS, OR STOPPAGE IN DELIVERY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE INTERMITTENTLY RESPONDING TO BUTTON PRESSES; THE KEYPAD WAS REMOVED AND CONTAMINATION WAS FOUND ON THE BUTTON CONTACTS. ALSO UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) FROM 200 MG/DL TO "HI" (GREATER THAN 600 MG/DL). SHE STATED THAT THERE WERE TWO SEPARATE BG READINGS OF "HI", WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. SHE STATED THAT THE PATIENT WAS TREATED BY BOLUSING VIA THE PUMP, AND HIS BG RESPONDED TO AROUND 200 MG/DL. THE SPECIFIC DATES FOR THE "HI" BGS WERE UNKNOWN. THE PATIENT'S BG AT THE TIME OF THE CALL TO ANIMAS CUSTOMER SUPPORT WAS REPORTEDLY 121 MG/DL. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE FAMILY MEMBER AND FOUND THAT ALL SETTINGS AND HISTORIES WERE CORRECT. THE FAMILY MEMBER DENIED SITE/SET ISSUES. SHE STATED THAT THE INSULIN WAS STORED IN THE REFRIGERATOR, AND THEY DID SOMETIMES SEE AIR BUBBLES WHEN FILLING THE CARTRIDGE. CS ADVISED THE FAMILY MEMBER TO PERIODICALLY CHECK THE TUBING FOR AIR BUBBLES, AS AIR BUBBLES MAY CAUSE OR CONTRIBUTE TO ELEVATED BGS. THE FAMILY MEMBER REPORTED THAT THE PATIENT WAS AT THE BEACH AND HAD BEEN LEAVING THE PUMP IN A BEACH BAG IN HOT TEMPERATURES. CS ADVISED THE FAMILY MEMBER TO AVOID SUN EXPOSURE TO THE PUMP AS HIGH TEMPERATURE CAN AFFECT THE INSULIN. THE FAMILY MEMBER STATED THAT THE PATIENT'S BASAL RATES AND INSULIN TO CARBOHYDRATE RATIO WERE RECENTLY CHANGED BY THE PATIENT'S ENDOCRINOLOGIST DUE TO THE ELEVATED BGS, AND THE PATIENT ALSO STARTED USING NEW SITES TO AVOID SCAR TISSUE. SHE NOTED THAT THE ENDOCRINOLOGIST THOUGHT THE PATIENT MAY HAVE INCREASED INSULIN NEEDS DUE TO PUBERTY. CS CONCLUDED THAT THERE WAS NO INDICATION OF A PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR